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Chloraseptic Sore Throat Spray

Generic Name: phenol
Dosage Form: oral spray

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Chloraseptic Sore Throat Grape Spray

Drug Facts

Active ingredient

Phenol 0.5%

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Purpose

Oral Anesthetic/Analgesic

Uses

For the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.

Warnings

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.


When using this product

do not exceed recommended dosage.

Stop use and ask a doctor or dentist if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 3 years of age and older:

  • Apply to the affected area (one spray).
  • Allow to remain in place for at least 15 seconds, then spit out.
  • Use every 2 hours or as directed by a doctor or dentist. Children under 12 years of age should be supervised in the use of this product. Children under 3 years of age: consult a doctor or dentist.

Other information

  • Store at room temperature.
  • Tamper Evident: Do not use if imprinted shrink band is broken or missing.
  • Check expiration date before using.

Inactive ingredients

FD&C Blue #1, FD&C Red #40, flavor, glycerin, purified water, sodium saccharin, sodium chloride

Questions?

1-800-552-7932 www.chloraseptic.com

PRINCIPAL DISPLAY PANEL

Kids Chloraseptic® Phenol/Oral Anesthetic
SORE THROAT
Real Relief, Real Fast®
GRAPE | 6 fl oz (177 mL)

CHLORASEPTIC SORE THROAT 
phenol spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67172-935
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOL (PHENOL) PHENOL 3.5 mg  in 0.7 mL
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1  
FD&C RED NO. 40  
WATER  
GLYCERIN  
SODIUM CHLORIDE  
Product Characteristics
Color PURPLE Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:67172-935-51 177 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part348 09/01/2010
Labeler - Prestige Brands Holdings, Inc. (159655021)
Establishment
Name Address ID/FEI Operations
Accupac, Inc. 071609663 MANUFACTURE
Revised: 10/2010
 
Prestige Brands Holdings, Inc.



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